CTRI/2017/03/008165 [Registered on: 21/03/2017] Trial Registered Retrospectively
Last Modified On:
14/03/2017
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Surgical/Anesthesia
Study Design
Randomized, Parallel Group Trial
Public Title of Study
"A clinical study to compare two procedure pratisaraniya ksharakarma and sclerotherapy along with oral medicine swalpasooranamodak in the management of arsha"
Scientific Title of Study
“A Comparative Clinical study of Pratisaraniya kshara along with Swalpsoorna modak and Sclerotherapy in the management of Arshaâ€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
CHINTAN GAMIT
Designation
PG SCHOLAR
Affiliation
Government Akhandanand Ayurved College Ahmedabad
Address
PG SCHOLAR Upgraded department of shalyatantra Government Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad GUJARAT 380001 India
Phone
9727099687
Fax
Email
chintangamit77@gmail.com
Details of Contact Person Scientific Query
Name
DR PRAGNESH PATEL
Designation
MS AYURVED
Affiliation
Government Akhandanand Ayurved College Ahmedabad
Address
LACTURER Upgraded Department of Shalya tantra Government Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad GUJARAT 380001 India
Phone
8140640999
Fax
Email
prayuin@gmail.com
Details of Contact Person Public Query
Name
DR PRAGNESH PATEL
Designation
MS AYURVED
Affiliation
Government Akhandanand Ayurved College Ahmedabad
Address
LACTURER Upgraded Department of Shalya tantra Government Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad GUJARAT 380001 India
Phone
8140640999
Fax
Email
prayuin@gmail.com
Source of Monetary or Material Support
Government Akhandanand Ayurved College and hospital Ahmedabad and Maniben Ayurved hospital Ahmedabad
Primary Sponsor
Name
Government Akhandanand Ayurved College and hospital Ahmedabad
Address
OPD and IPD of upgraded department of shalya tantra Government Akhandanand Ayurved College bhadra Ahmedabad 380001
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
CHINTAN GAMIT
GOVERNMENT AKHANDANAND AYURVEDIC HOSPITAL
opd no 24 shalyatantra department Government akhandanand Ayurvedic hospital Bhadra Ahmedabad 380001 Ahmedabad GUJARAT Ahmadabad GUJARAT
9727099687
chintangamit77@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
INSTITUTIONAL ETHICAL COMMITTEE
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
ARSHA ROGA(HAEMORRHOIDS/PILES),
Intervention / Comparator Agent
Type
Name
Details
Intervention
PRATISARANIYA APAMARGA KSHARA
Apamarga tikshna kshara applied on each pile mass in appropriate dose. Keep it for vaksat matra approx 2mins then washout with limejuice
duration one sitting only
swalpasoorna modak given orally 6gm per day till 6weeks
anupan lukewarm water
Inject sclerosing agent polidocanol3% in sub mucosa of pile mass in 0.5 to 1.5ml according to size of pile
Duretion one sitting only
orally swalpasoorna modak 6gms per day till 6weeks
Inclusion Criteria
Age From
20.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1st & 2nd degree internal piles.
With complaints of bleeding P/R & pain in ano.
Classical signs described by Acharya Sushrut; Achirkalin & Alpadoshlingupadrava.
ExclusionCriteria
Details
3rd & 4th degree piles.
Thrombosed & prolapsed piles.
Pappiloma, Condyloma & Sentinel tag.
Pile mass with excessive bleeding.
Fissure & fistula in ano.
Patient suffering from Carcinoma of rectum, Hypertension, DM, Cardiac, malignant systemic diseases excluded.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1 Bleeding P/R
2 Pain
3 Discharge
4 Reduction of size in pile mass
1 One day
2 one day
3 one day
4 one day
Secondary Outcome
Outcome
TimePoints
1 Bleeding P/R
2 Pain
3 Discharge
4 Reduction of size in pile mass
1 six weeks
2 six weeks
3 six weeks
4 six weeks
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
06/08/2016
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
Not published yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomised parellel group trial in department of department of shalya tantra OPD and IPD of government akhandanad ayurved college and hospital and maniben ayurved hospital asarva ahmedabad gujarat 380001 Dealing wirth the treatment of arsha. Acharya sushrut mentioned four type of tratment of the disease. (1)Bheshaj
chikitsa (Palliative treatment), (2)Kshara
karma (Potential caustic cauterization agent therapy), (3)Agni
karma (Direct cauterization),(4)Shastra
karma (Operation by sharp Instrument). Here performed kshara karma in arsha of apamarga tikshna kshara. on the other site in modern treatment with the same indication sclerotherapy is the line of treatment. in this inj polidocanol3% given. Group A: Inj Sclerotherapy, Group B: Pratisaraniya tikshna kshara in this both group swalpasoorana modak given orally post procedure with luke warm water. Assessment of pain, bleeding per rectum, discharge, size of pile mass done and compared of both this groups.